UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000049123 |
|---|---|
| Receipt number | R000055940 |
| Scientific Title | Evaluation of the effects of nicotineamide mononucleotide administered intravenously to healthy subjects. |
| Date of disclosure of the study information | 2022/10/11 |
| Last modified on | 2024/04/05 10:14:20 |
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Basic information
Public title
Evaluation of the effects of nicotineamide mononucleotide administered intravenously to healthy subjects.
Acronym
Evaluation of the effects of nicotineamide mononucleotide administered intravenously to healthy subjects.
Scientific Title
Evaluation of the effects of nicotineamide mononucleotide administered intravenously to healthy subjects.
Scientific Title:Acronym
Evaluation of the effects of nicotineamide mononucleotide administered intravenously to healthy subjects.
Region
| Japan |
Condition
Condition
healthy subjects
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to demonstrate the safety of NMN administered intravenously to healthy subjects and to explore its effects on various markers (intracellular mitochondrial amount, intracellular sirtuin expression, intracellular NAD+ concentration, and multiple serum cytokine levels) that have been suggested to be associated with aging.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Safety of intravenous administration of NMN.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
Intravenous administration of NMN
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | < |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Healhty men and women over 20 years old
Key exclusion criteria
(1) The subjects who suffer from serious cerebrovascular, cardiac, metabolic, hepatic, renal, gastrointestinal, or cancer diseases
(2) The subjects who habe an extremely irregular diet
(3) The subjects with serious allegic diseases
(4) Pregnant or possibly pregnant
(5) The subject who are currently participating in other clinical research or clinical trials, or those who habe participated in other clinical research or clinicl trals within the past three months
(6) The subjects who are judged as unsuitable for the study by the principal investigator or subinvestigator
(7) The subjects who lack judgment
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Takahiro |
| Middle name | |
| Last name | Otani |
Organization
TOKYO GINZA WELLNESS & AGING CLINIC
Division name
orthopaedic surgery
Zip code
104-0061
Address
1-14-4,2F,prairie Ginza Bldy.,Ginza,Chuo-ku,Tokyo
TEL
03-6263-2034
info@miraikai.or.jp
Public contact
Name of contact person
| 1st name | Yuji |
| Middle name | |
| Last name | Suzuki |
Organization
TOKYO GINZA WELLNESS & AGING CLINIC
Division name
Clinical Research Office
Zip code
104-0061
Address
1-14-4,2F,prairie Ginza Bldy.,Ginza,Chuo-ku,Tokyo
TEL
03-6263-2034
Homepage URL
y.suzuki@tgwaclinic.com
Sponsor or person
Institute
TOKYO GINZA WELLNESS & AGING CLINIC
Institute
Department
Personal name
Funding Source
Organization
TOKYO GINZA WELLNESS & AGING CLINIC
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics Review Board,Jiaikai
Address
1-14-4,2F,prairie Ginza Bldy.,Ginza,Chuo-ku,Tokyo
Tel
03-6263-2034
y.suzuki@tgwaclinic.com
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 10 | Month | 11 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Open public recruiting
Date of protocol fixation
| 2022 | Year | 09 | Month | 30 | Day |
Date of IRB
| 2022 | Year | 09 | Month | 21 | Day |
Anticipated trial start date
| 2022 | Year | 11 | Month | 07 | Day |
Last follow-up date
| 2027 | Year | 11 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2022 | Year | 10 | Month | 05 | Day |
Last modified on
| 2024 | Year | 04 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055940
